Drugs / Apomorphine
Apomorphine
also known as
Apomorphine hydrochloride · KW-6500 · APOKYN · apomorphine HCl · AZ-009 · Staccato Apomorphine · VR040 · APO-go PEN · +7 more
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Parkinson disease 2 milestones | |||||
| Filed | US (FDA) | — | Parkinson disease | 2020-09-14 | “submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its apomorphine infusion pump (SPN-830)” supernus.com ↗ |
| Filed | Japan (PMDA) | — | Parkinson disease | 2011-07-26 | “submitted a new drug application (NDA) to the Ministry of Health, Labour and Welfare for KW-6500 (Apomorphine hydrochloride hydrate)” kyowakirin.com ↗ |
| Withdrawn Indication not stated 5 milestones | |||||
| Label expansion | US (FDA) | KYNMOBI | — | 2022-09-22 | fda.gov ↗ |
| Label expansion | US (FDA) | APOKYN | — | 2017-03-16 | fda.gov ↗ |
| Withdrawn | EU (EMA) | Uprima | — | 2006-05-28 | europa.eu ↗ |
| Approved | US (FDA) | APOKYN | — | 2004-04-20 | fda.gov ↗ |
| Approved | EU (EMA) | Uprima | — | 2001-05-28 | europa.eu ↗ |
Trials 33
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06954428 | Jun → Dec 2025 | — | Nano PharmaSolutions Australia | Completed | No outcome recorded |
| Phase 1 | NCT04157933 | Oct 2019 → Feb 2020 | Parkinson disease | Alexza Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03822364 | Nov 2018 → Mar 2019 | Parkinson disease | Alexza Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 28 trials · 2 met primary | ||||||
| Phase 2 | NCT03623828 | Oct 2018 → Apr 2021 | — | University of Liege | Unknown | Met primary |
| Phase 2 | NCT03292016 | Aug 2017 → Mar 2019 | Parkinson disease | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03187301 | Aug → Dec 2017 | Parkinson disease | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 2 | NCT02702076 | May → Dec 2017 | Parkinson disease | University Medical Center Groningen | Unknown | No outcome recorded |
| Phase 2 | NCT00758368 | Mar 2009 → Jun 2011 | Parkinson disease | Oregon Health and Science University | Withdrawn | No outcome recorded |
| Phase 2 | NCT00437177 | Jan 2007 → Dec 2009 | alcohol dependence | Hospital Universitari Vall d'Hebron Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT01683292 | Jan → Jun 2006 | Parkinson disease | South Glasgow University Hospitals NHS Trust | Completed | No outcome recorded |
| Phase 2 | NCT00472355 | Oct 2005 → May 2007 | Parkinson disease | Oregon Health and Science University | Withdrawn | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT04879134 | Feb 2022 → Feb 2023 | Parkinson disease | University of Calgary | Unknown | No outcome recorded |
| Phase 2/3 | NCT05213169 | Jun 2021 → Dec 2026 expected | — | University of Liege | Recruiting | No outcome recorded |
| Phase 2/3 | NCT00346827 | Jul 2006 → Aug 2007 | Parkinson disease | Britannia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 2/3 | NCT00200512 | Sep → Nov 1999 | Parkinson disease | Mylan Bertek Pharmaceuticals | Completed | No outcome recorded |
| Phase 311 trials · 1 met primary | ||||||
| Phase 3 | NCT02864004 | Mar 2017 → Jan 2024 | Parkinson disease | Rennes University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02469090 | Jun 2015 → Dec 2017 | Parkinson disease | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 3 | NCT02339064 | Feb 2015 → Dec 2018 overdue | Parkinson disease | Supernus Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01504178 | May 2011 → Dec 2015 | Parkinson disease | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 3 | NCT01063621 | Jan 2010 → Aug 2011 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01058291 | Jan → Oct 2010 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00955318 | Jul 2009 → Dec 2010 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01039090 | Feb 2009 → Feb 2014 | Parkinson disease | Rennes University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00200525 | Jul 2001 → Jun 2002 | Parkinson disease | Mylan Bertek Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00145171 | Feb 2001 → Aug 2002 | Parkinson disease | Mylan Bertek Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00142545 | Jul 1999 → Jul 2005 | Parkinson disease | Mylan Bertek Pharmaceuticals | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT05529095 | Sep 2022 → Mar 2023 | restless legs syndrome | William Ondo, MD | Unknown | No outcome recorded |
| Phase 4 | NCT04887467 | Sep 2021 → Jun 2024 | Parkinson disease | Rennes University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02688465 | Sep 2016 → Jan 2017 | Parkinson disease | Fondation Ophtalmologique Adolphe de Rothschild | Terminated | No outcome recorded |
| Phase 4 | NCT02969629 | Dec 2012 → Dec 2014 | chronic pain syndrome | Rambam Health Care Campus | Completed | No outcome recorded |
| Phase 4 | NCT01770145 | Dec 2012 → Apr 2014 | Parkinson disease, akinetopsia, movement disorder | Supernus Pharmaceuticals | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT04957095 | Feb 2022 → Dec 2027 expected | Parkinson disease, essential tremor | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| — | NCT00524914 | Sep 2007 → Jan 2008 | Parkinson disease | University Hospital, Toulouse | Completed | No outcome recorded |
| Comparator or background therapy12 trials | ||||||
| Phase 0 | NCT01744964 Comparator | Jul 2009 → Jul 2011 | — | Rambam Health Care Campus | Completed | No outcome recorded |
| Phase 2 | NCT05979415 Comparator | Sep 2023 → Feb 2024 | Parkinson disease | Alexza Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT02230930 Comparator | Jun 2015 → Dec 2018 | Parkinson disease | University Medical Center Groningen | Terminated | No outcome recorded |
| Phase 2 | NCT00761228 Comparator | Jul 2010 → Dec 2018 | brain injury | NeuroHealing Pharmaceuticals Inc. | Suspended | No outcome recorded |
| Phase 2 | NCT00610103 Comparator | Nov 2007 → Oct 2008 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01693081 Comparator | Mar → Jul 2007 | Parkinson disease | South Glasgow University Hospitals NHS Trust | Completed | No outcome recorded |
| Phase 2 | NCT00040209 Background | Jun 2002 → Jul 2005 | Parkinson disease | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 3 | NCT03391882 Comparator | Dec 2018 → Aug 2021 | Parkinson disease | Sumitomo Pharma America, Inc. | Completed | Missed primary |
| Phase 3 | NCT02006121 Comparator | Mar 2014 → Jun 2016 | Parkinson disease | Britannia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT02940912 Comparator | Jan 2017 → Jan 2021 | Parkinson disease | Clinique Beau Soleil | Completed | No outcome recorded |
| Phase 4 | NCT02549573 Comparator | Jan → Dec 2016 | Parkinson disease, movement disorder | Supernus Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT03693872 Background | May 2019 → Jun 2022 | Parkinson disease | Rennes University Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2023-11-08 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Announces Third Quarter 2023 Financial Results supernus.com ↗
SPN-830 (apomorphine infusion device) NDA resubmission accepted for review by FDA; PDUFA date of April 5, 2024 |
| 2022-02-28 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Announces Preliminary Fourth Quarter and Full Year 2021 Financial Results supernus.com ↗
SPN-830 (apomorphine infusion device) NDA accepted for review by FDA; PDUFA date early October 2022 |
| 2020-11-09 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Provides Regulatory Updates for SPN-812 and SPN-830 supernus.com ↗
The Company received a Refusal to File (RTF) letter from the FDA regarding its NDA for SPN-830 (apomorphine infusion pump) |
| 2020-09-14 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Submits NDA for SPN-830 for Continuous Treatment of ON-OFF Episodes in Adults with Parkinson’s Disease Who Have Failed Two Treatments supernus.com ↗
today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its apomorphine infusion pump (SPN-830) |
| 2012-03-30 | Kyowa Kirin, Inc. | Regulatory Announcement regarding Marketing Authorization Approval in Japan of Apokyn® Subcutaneous Injection 30 mg (Apomorphine Hydrochloride Hydrate) for Treatment of Parkinson's Disease kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin") announces that it has received marketing authorization approval for Apokyn® Subcutaneous Injection 30 mg (Apomorphine Hydrochloride Hydrate, hereafter "Apokyn®") for treatment of Parkinson's disease. |
| 2011-07-26 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Submitted New Drug Application in Japan for KW-6500 (Apomorphine Hydrochloride Hydrate) kyowakirin.com ↗ |
All press releases naming this drug 8 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 45 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Apomorphine | “The purpose of this research project is to investigate the safety and tolerability of an approved drug (Apomorphine) when administered as a nasal powder spray formulation...” NCT06954428 ↗39“In a pivotal study, apomorphine sublingual film (APL; KYNMOBI®) was an effective and generally well-tolerated on-demand treatment of "OFF" episodes in patients with Parkinson's...” PMID 33991326 ↗ May 2021 “Inhaled apomorphine via Staccato aerosol, Dose 1 (low dose) each day for first 5 days, then 3 doses Dose 1 (low dose) q 2 hr on Day 6” NCT04157933 ↗ “Apomorphine sublingual film for off episodes in Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 study.” PMID 31818699 ↗ Dec 2019 “We assessed safety, tolerability and efficacy of inhaled dry powder apomorphine (VR040) in a clinic-based Phase II study.” NCT01693081 ↗ “Inhaled apomorphine, dry powder, VR040 at fine particle doses (FPD) of 0.2mg, 0.5mg and 0.8mg.” NCT01683292 ↗ “A Randomized Thorough QT Study of Apomorphine Sublingual Film in Patients With” PMID 35899977 ↗ Jul 2022 “Inhaled apomorphine via Staccato aerosol, Dose 1” NCT03822364 ↗ |
| Known as | APO-go PEN | “Pharmacokinetics and comparative bioavailability of APL and two subcutaneous (SC) apomorphine formulations (SC-APO [APOKYN®] and SC-APO-GO [APO-go® PEN]) were evaluated in a...” PMID 33991326 ↗ May 2021 |
| Known as | APOKYN | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01770145 ↗ |
| Known as | apomorphine HCl | “apomorphine HCl injection” NCT00145171 ↗1“apomorphine HCl injection” NCT00200512 ↗ |
| Known as | Apomorphine hydrochloride | “Apomorphine hydrochloride (started at 1 mg and titrated to a maximum of 6 mg) is subcutaneously administered.” NCT00610103 ↗2“Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe” NCT02006121 ↗ “Apomorphine Hydrochloride 5mg/ml” NCT05213169 ↗ |
| Known as | apomorphine sublingual film | “In this study, we assessed the safety and efficacy of apomorphine sublingual film as an on-demand therapy for off episodes in patients with Parkinson's disease.” PMID 31818699 ↗ Dec 2019 |
| Known as | AZ-009 | “A Randomized Study of the Safety, Tolerability, and Pharmacokinetics of AZ-009 (Staccato Apomorphine) in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, and...” NCT03822364 ↗1“Staccato Apomorphine (AZ-009)” NCT05979415 ↗ |
| Known as | KW-6500 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01063621 ↗ |
| Known as | KYNMOBI | “In a pivotal study, apomorphine sublingual film (APL; KYNMOBI®) was an effective and generally well-tolerated on-demand treatment of "OFF" episodes in patients with Parkinson's...” PMID 33991326 ↗ May 2021 |
| Known as | Movapo | “Other Names: Movapo” NCT04879134 ↗ |
| Known as | Movapo Pen | “The study also aims to compare the safety, tolerability and pharmacokinetics of NT-301 to an injectable Apomorphine product (Movapo Pen), already approved for use in Australia.” NCT06954428 ↗ |
| Known as | SC-APO | “Pharmacokinetics and comparative bioavailability of APL and two subcutaneous (SC) apomorphine formulations (SC-APO [APOKYN®] and SC-APO-GO [APO-go® PEN]) were evaluated in a...” PMID 33991326 ↗ May 2021 |
| Known as | SC-APO-GO | “Pharmacokinetics and comparative bioavailability of APL and two subcutaneous (SC) apomorphine formulations (SC-APO [APOKYN®] and SC-APO-GO [APO-go® PEN]) were evaluated in a...” PMID 33991326 ↗ May 2021 |
| Known as | SL-APO | “the effects of apomorphine sublingual film (SL-APO) on corrected QT interval (QTc)” PMID 35899977 ↗ Jul 2022 |
| Known as | Staccato Apomorphine | “A Randomized Study of the Safety, Tolerability, and Pharmacokinetics of AZ-009 (Staccato Apomorphine) in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, and...” NCT03822364 ↗1“Staccato Apomorphine (AZ-009)” NCT05979415 ↗ |
| Known as | VR040 | “We assessed safety, tolerability and efficacy of inhaled dry powder apomorphine (VR040) in a clinic-based Phase II study.” NCT01693081 ↗1“Inhaled apomorphine, dry powder, VR040 at fine particle doses (FPD) of 0.2mg, 0.5mg and 0.8mg.” NCT01683292 ↗ |
| Action | Activate | “Apomorphine (a dopamine agonist)” NCT01504178 ↗ |
| Route | Intravenous | “levodopa, and subsequently apomorphine, infused through a vein” NCT00040209 ↗ |